Kornimate/medical-research-clean huggingface dataset:
association between serum periostin levels and cortical porosity in patients with secondary hyperparathyroidism

Conditions: Hyperparathyroidism

Summary: based on the evidence that periostin is specifically involved in intra-cortical remodeling control, our working hypothesis is that assessment of its concentration in the serum would be helpful in identifying patients with severe cortical porosity, a critical parameter in bone fragility. periostin expression by osteoblasts and osteocytes is part of the bone cortical response to anabolic stimuli such as mechanical strain or intermittent increase in parathyroid hormone. however, it remains unknown whether this expression may participate as well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent bone loss. in rare clinical situations in which trans-iliac bone biopsies will be necessary to better understand their bone status in addition to densitometry and biological bone markers assessment, specific analyses using immune-staining techniques will be performed on the bone sample. data from routine follow-up every six months will be also collected in this specific sub-group. high resolution peripheral quantitative computerized tomography (hr-pqct) gives the opportunity of performing a virtual bone biopsy providing information on trabecular and cortical microarchitecture in vivo. these microarchitectural parameters allow a more accurate evaluation of the alteration of the bone structure and therefore of the fracture risk as compared to current tools used in clinical practice such as densitometry. however, the availability of such hrpqct facilities is limited and there is on-going development on the best way of measuring porosity for example. the definition of a biological profile including key proteins such as periostin and sclerostin involved in porosity mechanisms is therefore of great interest. a better understanding of the relationship between bone matrix components and parathyroid hormone effects also appears as critical. follow-up of routine evaluation parameters reflecting bone status in a subgroup of specific patients could also provide new and additional information.


Eligibility criteria:
inclusion criteria: * hyperparathyroidism defined by a parathyroid hormone serum level above 65 ng/ml, secondary to chronic kidney disease (ckd) ou vitamin d deficiency exclusion criteria: * concurrent bone disease (such as paget's disease, osteomalacia), * other endocrinopathy having an impact on bone metabolism (such as cushing, hyperthyroidism, severe hypogonadism (except menopause)), * current or previous bisphosphonate treatment. * transplantation * parathyroidectomy * life expectancy less than 3 months. * lack of study understanding. * lack of agreement. * under legal control.

Keywords: hyperparathyroidism microarchitecture periostin
atorvastatin to prevent avascular necrosis of bone in steroid treated exacerbated systemic lupus erythematosus

Conditions: Avascular Necrosis

Summary: this study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. the collapse of bone may require a surgical replacement of the joint and can be disabling for life. avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. we therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.

if you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. also, you would need to be enrolled in the study within three days of starting prednisone. if you are eligible you will receive lipitor 40mg per day or pills which look exactly like lipitor but do not contain any medication (called placebo). during the time of the study, you will not know if you are taking lipitor or the placebo. the period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 mri studies of the hips, knees and ankles.

Eligibility criteria:
inclusion criteria: * all individuals must fulfill 4 of the revised criteria of the american college of rheumatology for sle * patient started on corticosteroids at a dose of at least .5mg/kg for an interval greater than two weeks * to be able to come for all follow-up visits for nine months * no contraindications to undergoing mri * age 18-75 years exclusion criteria: * evidence of liver disease, not secondary to active lupus, or liver enzyme greater than 2x normal * elevated cpk at baseline * pregnancy or lactating * allergy to a statin * current or recent use of a statin within 3 months

Keywords: avascular necrosis lipitor sle
study of the safety and immune response of a meningococcal conjugate vaccine administered to healthy adolescents

Conditions: Prevention of Meningococcal Disease

Summary: the purpose of this study is to evaluate the safety and immunogenicity of novartis meningococcal acwy conjugate vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.


Eligibility criteria:
inclusion criteria: * healthy adolescents between and including 11-17 years of age, who provide written informed consent exclusion criteria: * subjects with a previous or suspected disease caused by n. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); any serious acute, chronic or progressive disease
using mhealth to aid opioid medication adherence pilot study

Conditions: Opioid Dependence

Summary: the purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.

the purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named subaid. the subaid system is a smartphone application and medication monitor designed to optimize adherence behaviors of an od patient responsible for administering bup/nal maintenance therapy medication. usability of the subaid system will be tested utilizing a 3-stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing ost. * stage 1 - 1 week: participants will use only an electronic medication monitor (medsignals) in control mode to passively record baseline adherence to medication. * stage 2 - 2 weeks: participants will use medsignals in control mode and the smartphone application. * stage 3 - 2 weeks: participants will use medsignals in active mode and the smartphone application. after each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.

Eligibility criteria:
inclusion criteria: * at least 21 years of age * physician diagnosis of opioid dependence (od) * prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication. * able to speak and read english * willing to provide written informed consent prior to study entry * able to understand the study * ownership of an android or iphone smartphone exclusion criteria: * having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or * cognitive or other impairment that would interfere with completing a self-administered questionnaire.

Keywords: opioid dependence, buprenorphine, smartphone, suboxone
population burden of sti and implication for intervention in hong kong

Conditions: STI

Summary: this is a 5-year cross-disciplinary sexually transmitted infection (sti) project involving a) territory-wide and community-based studies (survey and specimen collection); b) simulation of sti transmission dynamics and comparison of sti intervention strategies through mathematical modelling and cost-effectiveness analysis. the aim of this project is to assess the burden and the transmission dynamics of stis in the general population and men who have sex with men (msm) in hong kong. around 1300 sexually experienced adults and 900 msm would be recruited, 100 participants would be invited for individual in-depth interviews. main outcome measures include sti history and service preference, effectiveness as measured by the proportion of new sti infections (chlamydia, gonorrhoea and human papillomavirus infections) averted above base-case scenario, and incremental cost-effectiveness ratio.

after completion of baseline questionnaire, the participants are invitied for sti self-sampling. if agree, a package of self-sampling kits, instructions, and packaging materials for return post would be delivered to their selected collection points. the second round of self-sampling would be offered at least one year from the first round of self-sampled specimens collected.

Eligibility criteria:
inclusion criteria: * aged 18 or above * ever having sex * normally living in hong kong * can communicate in english or chinese exclusion criteria: * failed to provide consent

Keywords: chlamydia trachomatis neisseria gonorrhoeae human papillomavirus men who have sex with men general population
psma-pet/mri low- and intermediate-risk prostate cancer

Conditions: Prostate Cancer

Summary: the goal of this study is to determine the safety of using psma-pet/mpmri to define radiotherapy targets, while meeting all current planning criteria. this study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.

this study aims to determine if multi-parametric magnetic resonance imaging (mpmri) and prostate-specific membrane antigen-positron emission tomography (psma-pet) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. all radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. this study will focus those hot spots on regions determined by mpmri + psma-pet to have visible tumor.

Eligibility criteria:
inclusion criteria: * written informed consent obtained to participate in the study and hipaa authorization for release of personal health information * male subjects ≥ 18 years of age * histologically confirmed prostate adenocarcinoma * low or favorable intermediate risk, based on the nccn criteria * subject has adequate performance status as defined by ecog performance status of 0-2 * subject is willing and able to comply with the protocol as determined by the treating investigator * subject speaks english (quality of life instrument is validated in english) exclusion criteria: * contraindications for mri * other prior or concomitant malignancies, with the exception of: * non-melanoma skin cancer * other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence * inflammatory bowel disease * previous transurethral resection of the prostate (turp) or surgery of the prostate
a study to evaluate the efficacy and safety of deucravacitinib in adults with active sjögren's syndrome

Conditions: Sjögren's Syndrome

Summary: the purpose of this study is to assess the safety and efficacy of two doses of deucravacitinib in adult participants with active sjögren's syndrome.


Eligibility criteria:
inclusion criteria * satisfy the 2016 american college of rheumatology/european league against rheumatism criteria for the classification of sjs at screening (score ≥ 4), and who have disease duration (from time of initial clinical sjs diagnosis) of at least 16 weeks prior to screening. * have moderate to severe sjs essdai ≥ 5. * short duration of disease (≤ 10 years) before screening. * a stimulated whole salivary flow (swsf) ≥ 0.05 mililiters/minute (ml/minute). * positive anti-sjögren's syndrome-associated antigen a (anti-ro/ssa) at screening. exclusion criteria * autoimmune disease other than sjs (for example, rheumatoid arthritis, systemic lupus erthrematosus \[sle\], systemic sclerosis). * active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered. * medical condition associated with sicca syndrome. * previous exposure to tyrosine kinase 2 (tyk2) inhibitors such as deucravacitinib or related compounds. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: deucravacitinib sjogren's syndrome bms-986165 poetyk sjogren syndrome sjogren-larson syndrome gougerot-sjogren gougerot sjogren syndrome sjogren sjogren's sjogren disease sjogren's disease
personalized evidence-based medicine in patients with atrial fibrillation

Conditions: Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke

Summary: a retrospective analysis

4200 emr of patients at high risk for stroke with 1-year follow-up will be enrolled in the current study and analyzed by clinical decision support systems (cdss medicbk) utilizing a core laboratory.

Eligibility criteria:
inclusion criteria: emr only if an ecg diagnosis (12-lead ecg, 24-h holter, or other electrocardiographic documentation) confirming af was made in patients at high risk for stroke by cha2ds2-vasc (≥2 in men and ≥3 in women). exclusion criteria: no

Keywords: atrial fibrillation personalized evidence-based medicine clinical decision support systems stroke anticoagulation guidelines
sensitivity to acute cerebral ischemia in migrainers

Conditions: Ischemic Stroke; Migraine; Migraine With Aura

Summary: sensitivity to acute middle cerebral or intracranial carotid artery occlusion in migrainers (smco-mig) is a prospective multi-center study to determine if migraine induces a faster infarct growth as assessed by initial multimodal imaging.

ischemic stroke results from the occlusion of a brain artery by a clot. early revascularization by thrombolysis and thrombectomy promotes neurological recovery by saving the area of ischemic penumbra. progression of ischemic stroke is evaluated on multimodal imaging by the "mismatch ratio" between necrotized core and salvageable hypoperfused volumes. migraine affects 12% of the population. although considered as a benign condition, migraine, particularly with aura, is a risk factor for ischemic stroke. based on pathophysiological hypothesis and the result of one study, which had several limitations, it's suggest that migraine might increase the sensitivity to cerebral ischemia and induce a faster infarct growth. the main objective of the study is to determine if the mismatch ratio between irreversibly injured and hypoperfused volumes, measured on initial imaging (mri or ct) during acute ischemia due to occlusion of the middle cerebral artery or the intracranial internal carotid artery, varies according to the migraine status. a multicentric prospective cohort will be conduct, outcome study. the initial multimodal imaging (mri or ct) will be acquired routinely using a harmonized protocol in any patient suspected of an acute stroke. all consecutive patients eligible to the study will be included within 7 days of their initial admission, and evaluated with a short questionnaire classifying them as "migrainers" whose status will undergo a detailed validation at 3 months by a migraine expert, and "non-migrainers" whose status will be validated by repeating the short questionnaire at the follow-up visit at 3 months. all radiological data will be analyzed centrally after the end of the recruitment, by investigators blinded to the migraine status.

Eligibility criteria:
inclusion criteria: * males and females, 18 to 75 years old * admitted to a stroke unit for an acute ischemic stroke (\<12 h) * angiography showing m1/m2 or intracranial internal carotid artery occlusion * mri or ct acquired \<24h from is onset, using a harmonized protocol enabling calculation of the mismatch exclusion criteria: * individual enrolled into another study protocol with a period of exclusion still running at potential inclusion * coma, dementia, linguistic problem or aphasia preventing responding to the migraine questionnaire * refusal of participation * persons under legal protection, guardianship or curatorship

Keywords: migraine migraine with aura migraine without aura ischemic stroke mismatch
dynamic changes and risk factors of fibrosis and steatosis progression in nonalcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: it is an observational study of non alcoholic fatty liver disease (nafld) patients with a calculated sample size of 90. liver biopsy proved nafld patients will be recruited in this study for 2 years follow-up. patients will be assessed at baseline, at every six months for blood count, liver function test, fasting blood-glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness.

no.

Eligibility criteria:
inclusion criteria: * 1. 18-70 years of age, 2. liver biopsy proven non alcoholic fatty liver disease. 3. agree to be followed up regularly; 4. signature of written informed consent. exclusion criteria: * 1. patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease. 2. patients undergone bariatric surgery. 3. hiv infected patients. 4. pregnant women. 5. patients with severe diseases with expected survival less than 2 years. 6. patients had followings before liver biopsy: 1. hepatocellular carcinoma or suspected liver cancer, 2. decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 3. other malignancy, 4. undergone liver transplantation surgery. 7.patients with any other reasons not suitable for the study.

Keywords: non alcoholic fatty liver disease non alcoholic steatohepatitis steatosis fibrosis progression risk factors
study to evaluate the safety and efficacy of daily subcutaneous metreleptin treatment in subjects with pl

Conditions: Partial Lipodystrophy

Summary: this is a phase iii, double-blind, placebo-controlled, safety and efficacy study of daily sc metreleptin in subjects with partial lipodystrophy.


Eligibility criteria:
inclusion criteria: * diagnosis of familial partial lipodystrophy (fpld) * subjects with poor metabolic control defined as: hba1c ≥7% (at visit 1 and visit 3) and/or fasting tgs ≥500 mg/dl (5.65 mmol/l, at visit 1 and visit 3) * patients should be receiving optimized stable therapy exclusion criteria: * previous treatment with metreleptin * leptin levels \>20.0 ng/ml * acquired or radiation induced partial lipodystrophy (apl) other protocol defined inclusion/exclusion criteria apply

Keywords: metreleptin
development of novel imaging markers predicting the progression of abdominal aortic aneurysm using 3d computed tomography

Conditions: Abdominal Aortic Aneurysm (AAA)

Summary: study purpose: this study will investigate anatomical factors associated with increased risk of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on 3-dimensional analysis of ct images. study design: a multicenter single-arm prospective observational study. subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm (n=323) methods: patients diagnosed with small aaa based on ct will be enrolled after considering inclusion and exclusion criteria and prospectively followed clinically and with ct at 1 year. primary endpoint: major adverse aorta-related events (death, aortic rupture, or aneurysm growth \>0.4 cm per year) at 1 year secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth \>0.4 cm per year, surgical or endovascular repair 2) changes in ct parameters of aneurysm: diameter, volume, wall shear stress

prospective single-arm multicenter registry

Eligibility criteria:
inclusion criteria: - abdominal aortic aneurysm with maximum diameter of 30-50 mm exclusion criteria: * age \<19 years * serum cr\> 1.5mg/dl or egfr\<30 ml/min * known allergic reactions to iodine contrast media * women in pregnancy or women of childbearing age * abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic aneurysm or aneurysms with diameter \>5cm) * saccular type aneurysm, infected or inflammatory aneurysm * combined aortic dissection * aneurysms associated with genetic or connective tissue diseases (marfan syndrome, shprintzen-goldberg syndrome, loeys-dietz syndrome, takayasu's arteritis, behcet's disease) * past history of surgical or endovascular repair of aorta * any surgical or endovascular repair planned within 1 year * life expectancy \< 1 year

Keywords: abdominal aortic aneurysm ct risk factor
promoting informed choice for breast cancer screening

Conditions: Breast Cancer

Summary: identify the prevalence and predictors of reactance, self-exemption, disbelief, source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust.

in this study, the goal is to identify the prevalence and predictors of reactance, self-exemption, disbelief, and source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust. research has not yet systematically identified the proportion of women who respond negatively (vs. positively) to evidence about the benefits and harms of mammography screening, or attempted to explain these responses by examining theory-driven predictors. the investigator will develop and conduct a probability-based nationally representative survey in which mammography evidence is communicated using current best practices in risk communication. the investigators will identify theory-driven predictors of negative and positive responses to that evidence, and identify consequences of these responses for screening decision-making and trust.

Eligibility criteria:
inclusion criteria: * female * between 39-49 years of age * no history of breast cancer * no known brca 1/2 mutation exclusion criteria: * non-english or spanish speaking * persons unable to provide informed consent (e.g. sever dementia or cognitive disability or illiterate * history of breast cancer * known brca 1/2 mutation

Keywords: breast cancer screening
comparing ashc and cdsmp outcomes in arthritis

Conditions: Arthritis

Summary: the arthritis-specific arthritis self help course (ashc) and the more generic chronic disease self management program (cdsmp) teach generalizable skills for managing arthritis and other chronic diseases. in some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. however anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. the primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ashc or the cdsmp. the north carolina project is focusing primarily on african americans from 6 rural counties in north carolina. the results of this research will be used to guide arthritis program recommendations on the use of ashc and cdsmp to improve the quality of life for people with arthritis.


Eligibility criteria:
inclusion criteria: african american adults with arthritis caucasian adults with arthritis exclusion criteria: -

Keywords: arthritis chronic disease self management self efficacy